Celebrex Short Versus Long Therapy In Osteoarthritis Of The Knee

Phase 3

Completed

• Conditions: Osteoarthritis,Knee

• Registration Number: NCT00137410
• Lead Sponsor: Pfizer

Brief Summary

This is a phase III, multicentre, randomized, double blind, parallel-group, pilot study designed to compare a long term (12 weeks) versus a short term (2 weeks) treatment with celecoxib 200 mg/die in treatment and prevention of new flare in patients with osteoarthritis of the knee.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-29
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2006-07
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• diagnosis of OA of the knee according to the ACR Classification Criteria for osteoarthritis;
• patients in flare

Exclusion Criteria

• any concomitant inflammatory rheumatic condition which may interfere with the assessment of OA
• clinical or radiological evidence of chondrocalcinosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time elapsing between the last drug administration and a new flare, if any, occurring within a 12 months FU and proportion pts with a new flare

Secondary Outcome Measures

Name	Time	Method
Flare intensity WOMAC OA index Psycho-affective Index Pt's assessment of OA pain (VAS) Pt's & Physician's global assessment disease severity Incidence of total AEs Incidence of GI AEs: Incidence of changes in: hematology, renal function, liver function

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇹 Venezia, Italy